Compounding Center’s License Revoked
State regulators have voted to permanently revoke the license of the Framingham pharmacy at the center of nationwide outbreak of fungal meningitis, and Gov. Deval Patrick on Tuesday said the state would begin periodic, unannounced inspections of similar labs operating in Massachusetts.
The Department of Public Health released the preliminary finding of its month-old, ongoing investigation into the New England Compounding Center on Tuesday, and Bureau of Health Care Safety and Quality Director Madeleine Biondolillo reported “several health and safety deficiencies” at the drug compounding pharmacy.
The outbreak of fungal meningitis traced to NECC has affected people in 17 states and caused 23 deaths out of 308 total cases. The DPH, along with the U.S. Food and Drug Administration, have been investigating, and Patrick said a federal criminal investigation is also underway.
Senate President Therese Murray called the governor’s proposed actions “forceful and appropriate in light of this serious outbreak,” and said she has been meeting with Senate Minority Leader Bruce Tarr for the past two weeks to determine what law changes might be necessary to protect the public health.
“We remain concerned for all those affected by this turn of events, and once we identify and determine what the policy changes should be, we expect to file legislation in the next legislative session,” Murray said in a statement.
Biondolillo said NECC distributed large batches of injectable steroids for general use rather than patient-specific prescriptions in violation of its state pharmacy license, and investigators discovered several instances of unsanitary conditions at the lab and failures to follow sterilization procedures that could have contributed to the contamination.
The DPH investigation found that on 13 occasions NECC officials shipped medication from the three suspect batches of methylprednisolone acetate without waiting for the results of its own sterility testing to confirm the drugs were not contaminated.
Investigators also found that lab workers did not follow proper protocol for sterilizing products, did not test its sterilization equipment, and failed to properly clean the powder hoods used to protect pharmacists from inhaling substances during drug preparation. The residual powders found could have contributed to contamination, investigators reported.
Other possible causes of contamination found at the lab were “visibly soiled” mats used to trap dirt and dust from shoes prior to entry in the clean room and a leaking boiler adjacent to the clean room where drugs were sterilized.
Investigators observed a “visible black particulate matter” in several of the recalled vials of the injectable steroid traced to the meningitis outbreak.
According to officials and documents published online by the state, New England Compounding Center has had a history of complaints and probes into its practices, including the sterility of its labs. Biondolillo said three complaints against the lab were investigated in 2002 and 2003 resulting in a 2006 consent agreement with the state to improve its practices.
Asked whether the state should have imposed harsher discipline at the time, Biondolillo said the process was under review. Patrick said, “The very questions you’re asking, I’m asking, and the investigation continues around that. Let me be clear that in this administration we’re going to take a very different tact, a much more rigorous tact, because we’ve seen from this meningitis outbreak just how grave those consequences can be.”
Patrick, at a press conference in the State House, announced that Board of Registration in Pharmacy had voted to permanently revoke NECC’s license to operate in Massachusetts as well as the licenses of the company’s three principal pharmacists – Barry Cadden, Glenn Chin, and Lisa Conigliaro-Cadden. The decision can be appealed.
“Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again,” Patrick said.
Patrick also laid out steps the state would take to improve oversight of the 25 drug compounding pharmacies in operation in Massachusetts, including periodic and unannounced annual inspections, yearly reporting of production and volume and distribution of medications, and reporting to the state of all interactions with federal regulators.
The Board of Registration in Pharmacy carried out its first spot inspection Tuesday, and officials said information on where the inspection took place and the board’s findings would be released at a later time.
Patrick also said he would convene a special commission to report back before the end of the year on legislative steps the state could take to improve its oversight and pharmacy licensing laws and regulations.
“It’s also clear that our own rules here in Massachusetts governing compounding pharmacies have not kept pace with an industry that is changing rapidly,” Patrick said, indicating the practice of compounding has rapidly shifted from a hospital setting to a profitable business venture.
Patrick said he believed investigators at the Board of Registration in Pharmacy would “be able to keep up” with the inspection schedule he has called for, indicating the number of inspectors has been doubled in recent years.
According to the Department of Public Health, there are currently five inspectors, up from three when the governor took office in 2007. Those investigators carried out 329 licensure inspections and 223 complaint investigations in 2010, and 271 licensure inspections 336 complaint investigations in 2011.
Read more
Drug Compounders Fill Role Major Firms Cannot
State Officials Sift For Answers At NECC Hearing
Westborough Optimistic Ameridose Will Reopen
WBJ Web Partners
Most Recent
Most Recent
0 Comments